Core Insights - Tenaya Therapeutics, Inc. is set to announce initial data from the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) on December 17, 2024 [1] Company Overview - Tenaya Therapeutics is a clinical-stage biotechnology company focused on discovering, developing, and delivering potentially curative therapies for heart disease [4] - The company utilizes integrated capabilities such as target validation, capsid engineering, and manufacturing to create genetic medicines for both rare genetic disorders and common heart conditions [4] - Tenaya's pipeline includes several therapies: TN-201 for MYBPC3-associated HCM, TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction (HFpEF) [4] Upcoming Events - A live webcast and conference call will be held on December 17, 2024, at 8:00 a.m. ET to review the initial data from the MyPEAK-1 trial [2] - The webcast will be accessible on Tenaya's Investor Relations page [2][3]

Financial Performance - Total operating expenses for Q3 2024 were $26.7 million, down from $30.9 million in Q3 2023, reflecting a decrease of $4.2 million, or 14%[66]. - The net loss for Q3 2024 was $25.6 million, compared to a net loss of $29.1 million in Q3 2023, representing an improvement of $3.5 million, or 12%[66]. - Net loss for the nine months ended September 30, 2024, was $87.3 million, compared to a net loss of $94.1 million for the same period in 2023, reflecting an improvement of $6.8 million or 7%[77]. - Total operating expenses for the nine months ended September 30, 2024, were $91.3 million, down from $99.7 million in 2023, a decrease of $8.5 million or 8%[72]. - Cash, cash equivalents, and investments in marketable securities totaled $79.5 million as of September 30, 2024, with an accumulated deficit of $490.6 million[78]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $72.1 million, compared to $80.1 million in 2023, indicating a reduction of $8.0 million[86]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $47.4 million, primarily from a follow-on offering, compared to $3.7 million in 2023[88]. Research and Development - Research and development expenses decreased by $2.7 million, or 12%, from $23.1 million in Q3 2023 to $20.4 million in Q3 2024, primarily due to a workforce reduction plan and lower costs for outside lab services[69]. - Research and development expenses decreased to $68.1 million for the nine months ended September 30, 2024, from $75.2 million in 2023, a reduction of $7.1 million or 9%[74]. - The company continues to invest in new technologies and optimization of existing capabilities to support the development of gene therapies[63]. - The company has initiated the MyPEAK-1 Phase 1b/2 clinical trial for TN-201, with initial data expected in December 2024[62]. - TN-401 received FDA clearance for clinical testing and patient dosing is planned to begin in Q4 2024[63]. - TN-301 showed positive data in a Phase 1 clinical trial, indicating it was well tolerated and demonstrated dose proportionality[63]. - The company has received rare pediatric disease designation and orphan drug designation for TN-201 from the FDA[63]. - The Genetic Medicines Manufacturing Center is strategically located to support clinical studies and enhance manufacturing productivity[65]. Expenses and Cost Management - General and administrative expenses decreased by $1.5 million, or 19%, from $7.8 million in Q3 2023 to $6.4 million in Q3 2024, driven by reductions in employee-related costs and lower professional fees[70]. - General and administrative expenses were $23.2 million for the nine months ended September 30, 2024, down from $24.6 million in 2023, a decrease of $1.3 million or 5%[75]. - The company expects to continue incurring operating losses in the foreseeable future, with operating expenses anticipated to remain relatively flat for the next twelve months[83]. Company Classification and Compliance - The company is classified as an emerging growth company under the JOBS Act, remaining so until it exceeds $1.235 billion in annual revenue or meets other specified criteria[93]. - The company is also a smaller reporting company, with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million in the most recently completed fiscal year[93]. - The company may continue to qualify as a smaller reporting company if its market value remains below $250 million or if it maintains annual revenue below $100 million[93]. - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[93]. - The company has elected to use an extended transition period for complying with new or revised accounting standards, delaying adoption until it is no longer classified as an emerging growth company[93]. - The financial statements of the company may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates[93]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[94]. Funding and Financial Resources - The company has the right to draw down $20.0 million under a Loan Agreement with Silicon Valley Bank, with potential additional funds available upon meeting certain milestones[79][80]. - Interest income for the nine months ended September 30, 2024, was $3.9 million, down from $5.6 million in 2023, representing a decrease of $1.7 million or 30%[76].

Financial Position - As of September 30, 2024, Tenaya Therapeutics reported cash, cash equivalents, and investments in marketable securities of $79.5 million, sufficient to support operations into the second half of 2025[6]. - In August 2024, Tenaya entered into a $45 million credit facility with Silicon Valley Bank, which has not been drawn upon[5]. Expenses - Research and Development (R&D) expenses for Q3 2024 were $20.4 million, a decrease from $23.1 million in Q3 2023, while General & Administrative (G&A) expenses were $6.4 million, down from $7.8 million in the same period[6]. Net Loss - The net loss for Q3 2024 was $25.6 million, or $0.30 per share, compared to a net loss of $29.1 million, or $0.39 per share, for Q3 2023[6]. Clinical Trials - Tenaya completed dosing of the first three patients at the 3E13 vg/kg dose in the MyPEAK-1 clinical trial with no unexpected events or toxicities observed[3]. - The Data Safety and Monitoring Board (DSMB) endorsed the dose escalation to 6E13 vg/kg for Cohort 2 in the MyPEAK-1 study[3]. - Tenaya anticipates sharing interim results from MyPEAK-1, including safety and tolerability analyses, in December 2024[3]. - Tenaya activated six clinical sites for the RIDGE-1 trial, assessing TN-401 for ARVC, and has over 20 sites activated in six countries for the RIDGE seroprevalence and natural history study[4]. Regulatory Designation - The TN-201 gene therapy received rare pediatric disease designation from the FDA for treating MYBPC3-associated HCM in individuals under 18[3]. Intellectual Property - The U.S. Patent and Trademark Office issued U.S. Patent Number 12,104,165 for a method of treating ARVC with Tenaya's PKP2 gene therapy, expected to expire no earlier than 2040[4].

Data Safety and Monitoring Board Endorsed Dose Escalation and Broadening of Inclusion Criteria in the MyPEAKTM-1 Phase 1b/2 Trial of TN-201 Gene Therapy Initial TN-201 Data from Cohort 1 of MyPEAK-1 to be Reported in December 2024 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today ...

SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that Faraz Ali, Tenaya's chief Executive Officer, will participate in several upcoming investment conferences. Details are as follows: Morgan Stanley 22nd Annual Global Healthcare Conference Date: Thursday, September 5, ...

Financial Performance - The company reported a net loss of $29.4 million for the three months ended June 30, 2024, compared to a net loss of $33.3 million for the same period in 2023, reflecting a year-over-year improvement of $3.8 million, or 12%[54] - Net loss for the six months ended June 30, 2024, was $61.7 million, a decrease of 5% from a net loss of $65.0 million for the same period in 2023[64] - Net cash used in operating activities for the six months ended June 30, 2024, was $52.3 million, compared to $56.5 million in 2023[73] Operating Expenses - Total operating expenses decreased to $30.8 million in Q2 2024 from $35.1 million in Q2 2023, a reduction of $4.3 million, or 12%[54] - General and administrative expenses were $8.2 million in Q2 2024, down from $8.6 million in Q2 2023, reflecting a decrease of $0.5 million, or 5%[58] - Research and development expenses were $22.6 million for the three months ended June 30, 2024, down from $26.5 million in 2023, representing a decrease of $3.8 million, or 14%[56] - Research and development expenses decreased by $4.4 million, or 8%, to $47.7 million for the six months ended June 30, 2024, compared to $52.1 million in 2023[61] - General and administrative expenses remained flat at $16.9 million for the six months ended June 30, 2024, compared to $16.7 million in 2023[62] Cash Flow and Investments - Net cash provided by investing activities was $17.1 million for the six months ended June 30, 2024, compared to $33.1 million in 2023[74] - Net cash provided by financing activities increased significantly to $47.3 million for the six months ended June 30, 2024, primarily from a follow-on offering[75] - As of June 30, 2024, the company had cash, cash equivalents, and investments in marketable securities totaling $99.3 million[65] Funding and Financial Position - The company has an accumulated deficit of $464.9 million as of June 30, 2024[65] - The company expects to continue incurring operating losses and will require substantial additional funding to complete the development and commercialization of its product candidates[70] Clinical Development - The company initiated dosing in the MyPEAK-1 Phase 1b clinical trial for TN-201 in October 2023, with initial data expected in the second half of 2024[51] - TN-401 received FDA clearance for clinical testing in October 2023, with patient dosing planned to start in the fourth quarter of 2024[52] - TN-301 showed positive data in a Phase 1 clinical trial, indicating it was well tolerated and demonstrated dose proportionality, supporting its continued development for HFpEF[52] - The company received rare pediatric disease designation from the FDA for TN-201 in MYBPC3-associated HCM in July 2024[51] Workforce and Cost Management - A workforce reduction plan was implemented, resulting in a 22% decrease in personnel, aimed at cost containment while focusing on clinical-stage gene therapy programs[53] Interest Income - Interest income decreased to $1.4 million in Q2 2024 from $1.8 million in Q2 2023, a decline of $0.4 million, or 24%, primarily due to lower cash and investment balances[54] - Interest income decreased by $1.0 million, or 25%, primarily due to lower cash, cash equivalents, and investment balances[63] Company Classification - The company is classified as an emerging growth company under the JOBS Act and will maintain this status until it exceeds $1.235 billion in annual revenue or meets other specified criteria[80] - The company is also a smaller reporting company, with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million in the most recently completed fiscal year[80] - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company, including presenting only the two most recent fiscal years of audited financial statements[81] - The company has opted to use an extended transition period for complying with new or revised accounting standards, which may affect the comparability of its financial statements[80] - The company will remain a smaller reporting company if its market value remains below $250 million or if its annual revenue stays below $100 million while the market value is under $700 million[81] - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status[82]

Financial Performance - Tenaya Therapeutics reported a net loss of $29.4 million, or $0.34 per share, for Q2 2024, compared to a net loss of $33.3 million, or $0.45 per share, for the same period in 2023[7]. - General and Administrative (G&A) expenses for Q2 2024 were $8.2 million, compared to $8.6 million in Q2 2023, with non-cash stock-based compensation included in G&A at $2.4 million[7]. - Tenaya's total operating expenses for Q2 2024 were $30.8 million, down from $35.1 million in Q2 2023[10]. Cash and Funding - As of June 30, 2024, Tenaya had cash, cash equivalents, and marketable securities totaling $99.3 million, which is expected to fund operations into the second half of 2025[7]. - Tenaya established a $45 million credit facility with Silicon Valley Bank, allowing for up to $15 million upon closing and an additional $30 million based on milestones[6]. Research and Development - Research and Development (R&D) expenses for Q2 2024 were $22.6 million, down from $26.5 million in Q2 2023, with non-cash stock-based compensation included in R&D at $2.2 million[7]. - The company plans to initiate dosing in its Phase 1b trial of TN-401 in the fourth quarter of 2024, with four clinical sites activated[3]. - Tenaya anticipates sharing interim Phase 1b results from the first cohort of patients in MyPEAK-1 in the second half of 2024[2]. - Interim data from the RIDGE™ study indicated that 84% of adults with PKP2-associated ARVC had neutralizing antibody titers of less than 1:20, meeting eligibility criteria for the trial[4]. Regulatory Designation - Tenaya received Rare Pediatric Disease Designation from the FDA for TN-201, which may qualify the company for a priority review voucher upon approval[2].

Pediatric Cardiologist and Genetic Therapy Expert Barry J. Byrne, M.D., Ph.D., Joins Scientific Advisory Board Kathy Ivey, Ph.D., Vice President of Gene Therapy Research, will be promoted to Senior Vice President, Research, with responsibility for all Tenaya's non-clinical research and discovery work. Timothy Hoey, Ph.D., who has served as Tenaya's Chief Scientific Officer since 2017, will step down from his role. Dr. Hoey will remain with the Company in an advisory capacity, including joining Tenaya's Scie ...

Pediatric Cardiologist and Genetic Therapy Expert Barry J. Byrne, M.D., Ph.D., Joins Scientific Advisory Board SOUTH SAN FRANCISCO, Calif., June 27, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced changes to its Research leadership team, including new appointments to the company's Scientific Advisory Boar ...

SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that Faraz Ali, Chief Executive Officer, will participate in the TD Cowen Genetic Medicines & RNA Summit on Friday, June 21, 2024, at 11:20 am ET. The live presentation will be webcast and may be accessed from the Investo ...